Genzyme held a ceremony today in Geel, Belgium to mark the start of construction of a new €250 million ($336 million) plant and thus put it one step closer to pumping up production of its Pompe disease drugs. Boosting supply of Myozyme and Lumizyme is key for the company--particularly after a long manufacturing hiatus that caused shortages and rationing of its rare disease treatments. Powered by increased production capacity, the company is aiming to expand Myozyme's reach to 60 markets this year, up from 48.
Genzyme makes both drugs at an existing plant adjacent to the new Belgian site, which is also increasing production with a new bioreactor it expects to come online later this year; the company is aiming for a capacity of 12,000 liters there. Capacity at the new plant is designed to be 8,000 liters, with room for expansion. Genzyme hopes to gain commercial approvals for the facility by late 2014.
But what about Fabrazyme? As Pharmalot reports, that Fabry's disease drug is still running short in the U.S., and patients have been petitioning officials for help. First, patients asked the HHS to override Genzyme patents on the drug; NIH turned them down. Now, they're asking FDA to keep Genzyme from exporting so much of Fabrazyme overseas.
The patients say 62 percent of Fabrazyme stocks are allocated to overseas patients, and they want the agency to force Genzyme to supply U.S. patients first. After all, Europeans have easy access to another Fabry treatment, Replagal, which isn't currently approved in the U.S. (It is available under FDA's compassionate use program, however). The patients figure things won't get back to normal until Replagal gets U.S. approval.